Membership re Clinical Trials, Biologicals and Vaccines EAG
Dear Commission on Human Medicines,
Please provide me with;
(1) a full list of the names of your membership panel which made recommendations in relation to the first authorisation of the Pfizer Covid 19 vaccine (BNT162b2), and
(2) the documenation which was issued to the Minister (in the capacity of licensing authority) in order for the above mentioned authorisation of the Pfizer Covid 19 vaccine (BNT162b2) to be granted.
I look forward to hearing from you.
Yours faithfully,
A. I. Clayton
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References
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Our Ref: FOI 24/207
Dear A I Clayton,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 28th February 2024.
I confirm that your request is now being handled under the Freedom of Information Act 2000 and you should receive a reply within 20 working days from our date of receipt.
If you need to contact us again about this request, please quote the reference number above.
Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...
Kind Regards,
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
FOI 24/207
Dear A. I. Clayton,
Thank you for your request for information dated, 28 February 2024, we have included our responses below each of your questions.
"(1) a full list of the names of your membership panel which made recommendations in relation to the first authorisation of the Pfizer Covid 19 vaccine (BNT162b2), and"
Our response
We confirm that we hold the information you have asked for; however, this information is available to you as it is published in the summary minutes produced for the public available here:
https://app.box.com/s/jv487awvqzzsrdql0o...
Further information about the CHM can be found via the links on this page:
https://www.gov.uk/government/organisati...
Section 21 of the FOIA applies when the information is already reasonably accessible the requester and we do not need to provide a copy of the information.
"(2) the documentation which was issued to the Minister (in the capacity of licensing authority) in order for the above mentioned authorisation of the Pfizer Covid 19 vaccine (BNT162b2) to be granted."
Our response
You have made this request to the CHM, but it is the MHRA, a separate public authority, which holds the information rather than the CHM. We recognise that you have also asked for this information in your other request to the MHRA (24/189), and we have written to you separately to explain that we are working to finalise that response.
This concludes our response to your request.
If you have a query about this response, please contact us at [Commission on Human Medicines request email].
We trust that you will understand this position and the response. Please remember to quote the reference number at the top of this letter in any future communications (the correct ref is 24/207). Details of your appeal rights are below.
However, If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask us to review our actions and decisions by writing to: [Commission on Human Medicines request email], and requesting an internal review.
Please note that your internal review request must be in a recordable format (email, letter, audio tape etc.), and that you have 40 working days upon receipt of this letter to ask for a review. We aim to provide a full response to your review request within 20 working days of its receipt. Please quote the reference number above in any future communications.
If you are not content with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted online via an electronic form: https://ico.org.uk/make-a-complaint/foi-...
Or in writing to:
Information Commissioner's Office,
Wycliffe House,
Water Lane,
Wilmslow,
Cheshire,
SK9 5AF
Yours sincerely,
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
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